Vercellini 2003.
Methods | Method of randomisation in a proportion of 1:1 by a computer generated randomisation sequence using serially numbered sealed opaque envelopes. Single centre study. Open labelled study (single blind). Number randomised N = 100. Number of withdrawals N = 3, 2 in immediate surgery group (one became pregnant, and one opted for surgery at different hospital,1 in the GnRHa group had to undergo hysterectomy. Power calculation for sample size performed and analysis by intention to treat. Source of funding not reported. Triptorelin depot injections provided by IPSEN Biotech Pharmaceuticals, Milan, Italy. |
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Participants | Premenopausal women aged 18 to 40 years with symptomatic intramural or subserous fibroid > 3 cm were included. Exclusion criteria: If predominantly intracavitary fibroids, previous pelvic surgery for leiomyomas or other genital abnormalities,uterine malformations, present or past pelvic inflammatory diseases, use of GnRHa up to 6 months prior, ultrasonography showing signs of uterine calcifications, coagulation disorders and unstable general conditions. |
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Interventions | Rx: Intramuscular triptorelin depot injections 3.75 mg (Decapeptyl) on 2 occasions 28 days apart starting during mid luteal phase, N = 50. Control: Immediate surgery (abdominal myomectomy), N = 50. Duration: 2 months. | |
Outcomes | No preoperative evaluation. Operative Duration of surgery (minutes) Intraoperative blood loss (mL) Difficulty of surgery Frequency of blood transfusions Post operative Duration of hospital stay. Postoperative complications. Postoperative haemoglobin (g/dL). Postoperative haematocrit (%). Patient satisfaction (not included in the review). |
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Notes | No preoperative assessment | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "Treatment allocation was performed with a computer‐generated randomization sequence". |
Allocation concealment (selection bias) | Low risk | “...using serially numbered, opaque, sealed envelopes”. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Participants could not be blinded as they either received immediate surgery or treatment and delayed surgery. Study reported as "open label". |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Open label trial. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Withdrawals were low in number and were evenly distributed, and all available data appeared to be reported. After randomisation and before surgery, 3 women withdrew from the study, 2 from control group and 1 in triptorelin group and were not included in the analysis (reasons given). |
Selective reporting (reporting bias) | Low risk | It appears that all obvious outcomes were reported. |
Other bias | Low risk | Groups appear comparable at baseline. |